A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study
Purpose
The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286. Another secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.
Condition
- Multiple System Atrophy
Eligibility
- Eligible Ages
- Over 30 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria - is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive device (eg, cane, not walker) is allowed - is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination - Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits - Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods - Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods - Additional criteria apply; please contact the investigator for more information
Exclusion Criteria
- has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA - has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening - has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening - is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study - has a known hypersensitivity to any components of the IMP - is of a vulnerable population (eg, people kept in detention or jail) - participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study - Additional criteria apply; please contact the investigator for more information
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TEV-56286 |
Orally administered capsules once daily |
|
|
Placebo Comparator Placebo |
Orally administered capsules once daily |
|
Recruiting Locations
Teva Investigational Site 15554
La Jolla, California 92037
La Jolla, California 92037
Teva Investigational Site 15547
Washington, District of Columbia 20007
Washington, District of Columbia 20007
Teva Investigational Site 15544
Boca Raton, Florida 33486
Boca Raton, Florida 33486
Teva Investigational Site 15555
Tampa, Florida 33063
Tampa, Florida 33063
Teva Investigational Site 15546
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Teva Investigational Site 15736
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Teva Investigational Site 15552
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Teva Investigational Site 15549
New York, New York 10016
New York, New York 10016
Teva Investigational Site 15551
New York, New York 10032-3726
New York, New York 10032-3726
Teva Investigational Site 15553
Durham, North Carolina 27705-4410
Durham, North Carolina 27705-4410
Teva Investigational Site 15735
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
Teva Investigational Site 15543
Spokane, Washington 99202
Spokane, Washington 99202
More Details
- NCT ID
- NCT06568237
- Status
- Recruiting
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Detailed Description
We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, and Japan